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临床试验/NCT04432129
NCT04432129已完成不适用

Integrated Mental Health Care and Vocational Rehabilitation Intervention to Individuals on Sick Leave Due to Anxiety, Depression, Personality Disorders, Stress and Functional Disorders

Amager Hospital1 个研究点 分布在 1 个国家目标入组 900 人开始时间: 2020年6月9日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
900
试验地点
1
主要终点
Return to work

研究概览

简要总结

The purpose of this study is to investigate the efficacy of an integrated mental health care and vocational rehabilitation intervention for people on sick leave because of depression, stress, anxiety, personality- and functional disorders in Denmark

详细描述

Background:

Mental illness has an estimated financial burden on the Danish economy of 3.4 % of Gross National Product every year due to lost productivity, social benefits and healthcare costs and approximately 50 % of people receiving long-term sickness benefits have a common mental illness. Furthermore, a significant treatment gap exists where less than 30% were treated for their mental illness.

Objective:

The primary objective of the randomized trial is to examine whether people on sick leave with a diagnosis of anxiety, depression, stress, personality disorders or functional disorders, return to work faster and have a higher job retention if they receive an integrated and optimized vocational rehabilitation and mental health care intervention, compared to people who receive the standard mental health care and vocational rehabilitation service.

Method:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • - Inclusion criteria
  • Anxiety, depression, stress, personality disorder or functional disorder diagnosed at a structured diagnostic interview based on the Mini International Neuropsychiatric Interview conducted by the IBBIS team
  • Sickness benefit recipient at baseline; on sick leave from job or unemployed for a minimum of four weeks
  • Resident in Copenhagen or Aarhus municipalities
  • Speak sufficient Danish to participate in interviews and complete questionnaires without an interpreter
  • Aged 18 or older
  • Has given informed written consent

排除标准

  • High degree of suicidal ideation
  • Abuse of alcohol or other drugs to the degree that participation in therapy is not possible
  • A need for mental health treatment in secondary sector care
  • Unstable somatic condition that is too severe for participation in the project
  • The participant will not refrain from participating in other psychotherapeutic treatment outside the IBBIS project if the participant will be allocated to the experimental group

研究组 & 干预措施

IBBIS II

Experimental

Integrated Mental Health Care and Vocational Rehabilitation

干预措施: IBBIS II (Behavioral)

Service As Usual

Active Comparator

Standard vocational rehabilitation and treatment

干预措施: Service as Usual (Behavioral)

结局指标

主要结局

Return to work

时间窗: 12 months

Difference between the two groups in time to return to work from baseline until 12 months after baseline measured whit register based data. Time to return to work is defined as a minimum of four weeks of continuous work without receiving sickness benefit.

次要结局

  • Work at one point during follow-up(12 months)
  • Return to work(6 months)
  • Supported work at one point during follow-up(12 months)
  • Weeks of work(12 months)
  • Time to new sick leave(12 months)
  • Income(12 months)
  • Use of psychiatric services(12 months)
  • Use of private health care(12 months)
  • Use of somatic services(12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Lene Falgaard Eplov

Head of Research, Associate professor

Amager Hospital

研究点 (1)

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